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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS001
Date Received03/31/1997
Decision Date03/13/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a capacitive sensor, integrated circuit change and its supporting circuityr, hybrid circuit modification, battery change, pacemaker housing change, modified header, PMS 1000 C programmer, and the SWM 1000 F01.B00.U Software. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following:Actros DR, D, SR, and S models, PMS 1000 C programmers, SWM 1000 (Version F01.B00.U). Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrom (i.e., bradycardiatachcardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of te dual-chamber or atrial pacing modes. Dual-chamber modes are specfically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with coduction distrurbances, and tachyarrhythmias that are suppressed by chronic pacing.
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